talbott v. c.r. bard, inc., 1st cir. (1995)
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USCA1 Opinion
UNITED STATES COURT OF APPEALS
FOR THE FIRST CIRCUIT
____________________
No. 94-1951
LINDA TALBOTT, ETC., ET AL.,
Plaintiffs, Appellants,
v.
C.R. BARD, INC., ET AL.,
Defendants, Appellees.
____________________
APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MASSACHUSETTS
[Hon. Mark L. Wolf, U.S. District Judge] ___________________
____________________
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Before
Stahl, Circuit Judge, _____________
Campbell, Senior Circuit Judge, and ____________________
John R. Gibson,* Senior Circuit Judge. ____________________
____________________
Jeffrey S. Beeler with whom Jeffrey A. Newman and Ne _________________ __________________ __
Heineman & Itzkowitz were on brief for appellants. ____________________
Francis C. Lynch with whom Daryl J. Lapp and Palmer &________________ _____________ _________
were on brief for appellee C.R. Bard, Inc.
Robert D. Keefe with whom Hale and Dorr was on brief________________ _____________
appellee David Prigmore.
William H. Kettlewell with whom Dwyer & Collora was on b
_____________________ _______________
for appellee John Cvinar.
Michael S. Raab, Attorney, Civil Division, with whom_______________
W. Hunger, Assistant Attorney General, Donald K. Stern, Un __________ ________________
States Attorney, Douglas N. Letter, Appellate Litigation Coun _________________
United States Department of Justice, and Margaret Jane Por _________________
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Chief Counsel, and Beverly Rothstein, Attorney, Food and__________________
Administration, were on brief for the United States, a
curiae.
____________________
August 14, 1995
____________________
*Of the Eighth Circuit, sitting by designation.
____________________
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CAMPBELL, Senior Circuit Judge. Section 360k(a)____________________
the Medical Device Amendments ("MDA") to the Food, Drug a
Cosmetic Act ("FDCA") provides:
[N]o State or political subdivision of a
State may establish or continue in effect
with respect to a device intended for
human use any requirement --
(1) which is different from,
or in addition to, any
requirement applicable under
this chapter to the device, and
(2) which relates to the
safety or effectiveness of the
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device or to any other matter
included in a requirement
applicable to the device under
this chapter.
21 U.S.C. 360k(a) (1988). This appeal presents t
questions: (1) whether the above provision applies to sta
tort law claims asserted against a medical devi
manufacturer; and (2) if so, whether there is an exception
the preemption clause where the manufacturer fails to comp
with the MDA. We hold that the answers to the two questio
are, respectively, yes and no. We therefore affirm t
district court's dismissal of this case for failure to sta
a claim under Fed. R. Civ. P. 12(b)(6).
I.
It is unnecessary to set out the facts a
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procedural background at length as these are in the distri
court's comprehensive opinion. Talbott v. C.R. Bard, Inc _______ ______________
865 F. Supp. 37, 39-52 (D. Mass. 1994) (sections I and II.
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3
To orient the reader of this opinion, we provide only t
following brief summary. On December 28, 1988, Euni
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Beavers died on the operating table during an angioplas
procedure when a heart catheter failed to deflate whi
inserted in one of her coronary arteries. Her heirs, Lin
Talbott et al., sued the manufacturer of the heart cathete
C.R. Bard, Inc. ("Bard"), and two members of its manageme
for wrongful death, alleging numerous state tort clai
negligence, breach of express and implied warrantie
punitive damages, negligent infliction of emotional distres
fraudulent misrepresentation and concealment, neglige
hiring, civil conspiracy, unfair trade practices. T
district court dismissed the complaint under Fed. R. Civ.
12(b)(6), finding that all the claims were preempted by
360k(a) of the MDA. Plaintiffs now appeal.
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II.
To determine whether federal law preempts sta
law, we look to the intent of Congress: congressional inte
to displace state law must be "clear and manifest" befo
preemption is found. Rice v. Santa Fe Elevator Corp., 3 ____ ________________________
U.S. 218, 230 (1947). Such intent may be expressed eit
explicitly, in the language of a statute, or implicitl
through passage of a statutory scheme that extensive
occupies the field or where the purpose and objectives
federal law would be frustrated by state law. Here, Congre
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has manifested its intention an explicit preemption clause,
360k(a). Thus, absent any "general, inherent conflic
between state and federal law, we need only ascertain t
preemption Congress intended. Freightliner Corp. v. Myric __________________ ____
115 S. Ct. 1483, 1488 (1995); Cipollone v. Liggett Group, 1 _________ _____________
S. Ct. 2608, 2617-18 (1992). We review the district court
reading of the clause de novo, taking all of plaintiff
__ ____
factual averments as true and indulging every reasonab
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inference in plaintiffs' favor. Garcia Hotel Lt _________________
Partnership v. Ponce Federal Bank, 958 F.2d 15, 17 (1st Ci ___________ __________________
1992).
A. State Tort Law Imposes Requirements
___________________________________
Plaintiffs insist that the district court erred
concluding that state tort law imposes a "requirement"
that term it used in 360k(a). Plaintiffs argue t
Congress meant "requirement" to include only the state
positive enactments such as statutes and regulations
and not common law causes of action. This issue, howeve
has been resolved against plaintiffs in this circuit in t
decisions: King v. Collagen Corp., 983 F.2d 1130, 1135- ____ _______________
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(1st Cir.), cert. denied, 114 S. Ct. 84 (1993), and Mendes____________ ______
Medtronic, Inc., 18 F.3d 13, 16 (1st Cir. 1994). In bot _______________
this court has ruled that Congress understood state tort l
to impose a "requirement" such as to subject state tort l
to the MDA's preemption clause. Where the requirement
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"different from, or in addition to" the requirement impos
by the MDA, state tort law will be preempted. A li
construction has been adopted by every other circuit cou
that has considered the issue.1 Plaintiffs argue that
should overrule King and Mendes as having been wrongl ____ ______
decided. However, except in certain circumstances n
present here, the prior decisions of panels of this court
be overruled only by the full court en banc. United Stat __________
v. Newman, 49 F.3d 1, 11 (1st Cir. 1995). We accordingly,
______
hold that state tort law falls within 360k(a).
B. No Exception For Non-Compliance _______________________________
Plaintiffs next argue that, even assuming 360k(
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applies to state tort law generally, the district court err
in holding that it applies where a manufacturer has failed
comply with the provisions of the MDA by fraudulent
obtaining approval from the Food and Drug Administrati
("FDA"). Plaintiffs argue that, in enacting 360k(a
Congress intended to preempt only state laws that sought
impose liability on manufacturers who were already complyi
____________________
1. See, e.g., Anguiano v. E.I. Du Pont De Nemours & Co.,___ ____ ________ _____________________________
F.3d 806, 809 (9th Cir. 1995) (dicta); Martello v. CI ________ _
Vision Corp., 42 F.3d 1167, 1168 (8th Cir. 1994), cer _____________ __
denied, 63 U.S.L.W. 3904 (1995); Gile v. Optical Radiati ______ ____ ______________
Corp., 22 F.3d 540, 542 (3d Cir.), cert. denied, 115 S. C _____ ____________
429 (1994); Duncan v. Iolab Corp., 12 F.3d 194, 195 (11 ______ ___________
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Cir. 1994) (per curiam); Stamps v. Collagen Corp., 984 F. ______ ______________
1416, 1420-21 (5th Cir.), cert. denied, 114 S. Ct. 86 (1993 ____________
Slater v. Optical Radiation Corp., 961 F.2d 1330, 1333 (7
______ ________________________
Cir.), cert. denied, 113 S. Ct. 327 (1992). ____________
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with the MDA. Congress did not, plaintiffs assert, intend
afford such protection to manufacturers who failed to comp
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with the provisions of the MDA. Such a result wou
conflict, in plaintiffs' view, with the MDA's basic purpo
of protecting individuals from unreasonably dangerous a
defective medical devices. Where a manufacturer has fail
to comply with the MDA, state tort liability would mere
impose additional state sanctions for noncompliance with t
MDA. Here, plaintiffs argue, Bard clearly violated t
provisions of the MDA by submitting false data to the FDA
order to obtain approval of its heart catheters.
As the district court explained, Talbott, 865_______
Supp. at 41-42, Bard pled guilty in an earlier proceeding
a criminal indictment charging it with conspiring to defra
the FDA in connection with applications for pre-mar
approval of its heart catheters. Bard was eventually forc
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to pay civil and criminal fines totaling $61 million. Unit ___
States v. C.R. Bard, Inc., 848 F. Supp. 287, 289 (D. Mas ______ _______________
1994). There is some dispute between the parties as
whether Bard's guilty plea admitted wrongdoing with respe
to the particular heart catheter used in Mrs. Beavers
angioplasty. As this is a motion to dismiss, however,
accept plaintiffs' version of the facts. Watterson v. Pa _________ __
987 F.2d 1, 3 (1st Cir. 1993). Thus, for present purposes
shall assume that Bard fraudulently obtained approval for t
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heart catheter by submitting false information to the F
The question is whether 360k(a) applies despite su
fraudulent activity.
The latter issue may already have been resolved
this circuit against plaintiffs. In King, the plainti ____
contended that the manufacturer had fraudulently obtained
approval and that the MDA's preemption clause therefore
not apply. Judge(now Chief Judge) Torruella, in the opini
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for the court, did not reach the question, construing t
fraud claim as essentially a failure to warn claim preempt
by the MDA. In what was titled a "concurrence," however, t
two other judges on the panel expressed the opinion t
there was no exception to the MDA's preemption clause f
cases in which the manufacturer failed to comply with t
MDA. As two judges of the panel took this view, it
arguably now stare decisis.
If so, however, a separate panel in Men ___
overlooked the fact. The plaintiff in Mendes did not ma ______
the exception-for-noncompliance argument made by t
plaintiff in King, arguing merely that the MDA did not app
____
to state tort law. However, at the end of the opinion, t
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panel wrote:
We express no opinion on whether products
liability claims are preempted only if
the manufacturer complied with applicable
FDA regulations. The complaint contains
no allegations regarding Medtronic's
noncompliance with FDA regulations, and
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plaintiff has offered no evidence that
Medtronic violated any FDA requirement.
Our holding is limited to the facts and
claims in this case.
Mendes, 18 F.3d at 19-20 (citations omitted). The dicta______
Mendes can be read (and plaintiffs argue should be read)______
indicate that the issue is still open in this circui
Alternatively, it might mean only that the panel in Men ___
did not pay close attention to the concurrence in King, sin ____
that issue was not before it. Given the uncertain
regarding the precedential status of the King concurrence,
____
shall address the arguments anew, as the district court di
We hold that Congress did not intend to provide f
an exception to the MDA's preemption clause where
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manufacturer fails to comply with the provisions of the
by fraudulently obtaining approval of its device from t
FDA. In so holding, we reach the same result reached by t
King concurrence and by the two circuit courts of appeal t ____
have expressly addressed this exact issue. See Reeves___ ______
Acromed Corp., 44 F.3d 300, 307 (5th Cir.) (finding_____________
exception to preemption where a manufacturer fraudulent
obtained FDA approval), cert. denied, 115 S. Ct. 2251 (1995 ____________
Michael v. Shiley, 46 F.3d 1316, 1329 (3d Cir. 1995) (same _______ ______
petition for cert. filed, 63 U.S.L.W. 3874 (U.S. June__________________________
1995).
Section 360k(a) preempts broadly any state tort l
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"requirement" that is "different from, or in addition to" t
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9
comprehensive and detailed requirements set forth by feder
law. The terms of the statute make no distinction based up
whether or not a manufacturer has in fact complied with t
federal standard. We find nothing to indicate t
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preemption is conditional upon satisfactory compliance wi
the federal standard. Section 360k(a) does not menti
compliance at all. As 360k(a) reads, the relevant inqui
is simply whether, in the abstract, the state tort l
requirement is "different from, or in addition to" t
federal requirement. If a device manufacturer fails to me
the federal requirements, it will be subject to feder
penalties as set forth in the MDA. Nothing in 360k(
suggests that the state requirements are somehow revived
this failure to comply with the federal standard.
Plaintiffs argue that state tort claims would n
impose a "requirement" that is "different from, or
addition to" federal requirements so long as the state ju
instructs the jury that a manufacturer's obligations un
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state tort law were defined by the provisions of the M
Given such an instruction, plaintiffs say, state tort l
would not be imposing any additional requirements, but wou
only compensate the victim ex post for failure to meet t
MDA standards. This theory of cooperative preemptio
however, was expressly rejected, albeit in dictum, in Mende ____
One way to ensure that a [state]
factfinder applies a standard not adding
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to or differing from FDA regulations is
to supplant the common law standard with
FDA's requirements. We find nothing to
support that Congress intended such a
radical, unwieldy form of preemption,
however, particularly where Congress did
not intend to create a private right of
action under the Federal Food, Drug, and
Cosmetic Act.
Mendes, 18 F.3d at 19 n.4. It has also been rejected by______
number of other circuit courts of appeal. See Lohr___ ____
Medtronic Inc., 56 F.3d 1335, 1343 (11th Cir. 1995) (holdi ______________
that "preemption under the MDA cannot be defeated by a com
lawsuit alleging a violation of the statutory standards"
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Michael, 46 F.3d at 1329 (holding that "states have_______
authority to police . . . compliance with the FD
procedures").2
Allowing an exception for noncompliance wou
disturb the balance Congress struck between the competi
goals of protecting individuals from unreasonably dangero
medical devices and spurring innovation by ensuring t
device manufacturers are subject to uniform, nationwi
standards. See Mendes, 18 F.3d at 16; S. Rep. No. 33, 94 ___ ______
Cong., 2d Sess. 5, 12 (1975), reprinted in 1976 U.S.C.C.A. ____________
____________________
2. But cf. National Bank of Commerce v. Kimberly-Cla _______ ___________________________ ___________
Corp., 38 F.3d 988, 992 (8th Cir. 1994) (holding that "when_____
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statute only preempts state requirements that are differe
from or in addition to those imposed by federal la
plaintiffs may still recover under state tort law w
defendants fail to comply with the federal requirements"
Slater, 961 F.2d at 1334 (stating in dicta that preempti ______
under 360k(a) "is limited to efforts by states to impo
sanctions for compliance with federal regulations").
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1070, 1074, 1081). To see how this is so, we need on
imagine how such an exception would operate in practice.
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state tort claims were allowed to go forward, a state cou
would initially have to determine whether the manufactur
had complied with the MDA. If, as in this case, t
plaintiff claimed that the manufacturer had defrauded t
FDA, the state court would need to determine whether the
had in fact been defrauded and whether the FDA would ha
approved the device absent the fraud. Under this scheme,
device manufacturer could potentially be subject to numero
inconsistent interpretations and applications of the
across different states, thus undermining the MDA's goal
uniformity. Moreover, if state courts erred in the
application of the MDA, they would effectively be imposi
requirements "different from, or in addition to" tho
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imposed by federal law. See King, 983 F.2d at 1139-4 ___ ____
Talbott, 865 F. Supp. at 47. _______
To avoid the possibility of disuniform treatmen
Congress placed enforcement authority in the FDA. The
has the broad power: to withdraw approval of a device if
determines that the device is unsafe or its labelli
inadequate, 21 U.S.C. 360e(e); to order a recall of t
device, 360h(e); and to initiate criminal prosecutio
against manufacturers, as it did in this case against Bar
Bard, 848 F. Supp. at 287. Centrally situated and with t ____
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requisite expertise, the FDA is in the best position
determine whether the provisions of the MDA have in fact be
violated and to ensure that the law is applied in a unifo
manner. See Michael, 46 F.3d at 1329. Given the FD ___ _______
central enforcement role, the preemptive scope of 360k(
becomes clear, as the districtcourt in this case aptly note
As applied in this case, the express
preemption provided by 21 U.S.C.
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360k(a) manifests a decision by Congress
to replace completely the private rights
of action usually available under state
law with civil and criminal enforcement
by the federal government when thoroughly
regulated devices such as Bard's heart
catheter, are at issue. This judgment
represents a permissible decision by
Congress that the public interest will
best be served by relying exclusively on
the FDA to strike the proper balance
between reasonably assuring safety and
promoting innovation with regard to new
devices that have the potential both to
enhance and injure human health.
Talbott, 865 F. Supp. at 40; see also Reeves, 44 F.3d at 30 _______ ___ ____ ______
The United States, as amicus curiae, argues t
such reasoning, while perhaps applicable in King, is n ____
applicable in this case, because the FDA has alrea
determined that Bard failed to comply with the requiremen
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of the MDA by submitting fraudulent data to the FDA. Thu
the concerns about disuniformity are not implicated in t
case. Under the United States' scheme, then, a plainti
would simply need to prove, not that the manufacturer fail
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to comply with the MDA, but that the FDA had determined t
the manufacturer failed to comply.
Although this may be a workable arrangement,
still does not get around the problem that neither t
language of 360k(a) nor the legislative history give a
hint of congressional intent to create such a uni
exception to the MDA's preemption clause. It may or may n
be that allowing injured plaintiffs to recover in sta
actions when the FDA has determined that a manufactur
violated the MDA would be a desirable rule, from a poli
standpoint. Congress, however has not provided for suc
remedy, choosing instead to place sole enforcement authori
in the hands of the FDA. See, e.g., Mendes, 18 F.3d at 19___ ____ ______
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4 (no federal private right of action under the MD
Rodriguez v. SK & F Co., 833 F.2d 8, 9 (1st Cir. 1987) (p _________ ___________
curiam) (same). As the district court aptly noted:
Congress could reasonably decide that
when the FDA has already established it
was defrauded, private rights of action
to recover damages on behalf of injured
individuals are appropriate. Where, as
here, it is well-established that there
is generally no private right of action
to enforce the MDA, if Congress intends
to create an exception for fraud which
has already been demonstrated by the FDA,
it should say so clearly. In view of the
unqualified language of the MDA's present
preemption provision, however, this court
does not have a proper basis for
inferring that such an exception was
intended.
Talbott, 865 F. Supp. at 47. _______
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The absence of a non-compliance exception does n
mean that individuals injured by noncompliance will always
without compensation. In a criminal judgment against
manufacturer, a court may, as part of any sentence, awa
restitution to those harmed. See 18 U.S.C. 3663(a)(1 ___
Bard, 848 F. Supp. at 292-93. While the district cou ____
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accepted a binding plea agreement from Bard that contained
restitution provision, it did so, in part, because
erroneously believed that civil proceedings could provi
appropriate compensation. Talbott, 865 F. Supp. at 47-4 _______
Bard, 848 F. Supp. at 293. Courts in future crimin ____
proceedings will, or should, be aware that restitution may
the only redress for those harmed by manufacturers who ha
failed to comply with the provisions of the MDA.
Like the court below, we cannot find any excepti
to 360k(a) where a manufacturer of a Class III device
failed to comply with the requirements of the MDA.
C. Application of Preemption Clause ________________________________
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Having held that the MDA's preemption clau
applies to state tort law, whether or not the manufactur
has complied with the provisions of the MDA, we must ne
determine whether the requirements imposed by plaintiff
numerous state law claims are "different from, or in additi
to" the ones imposed by the MDA. In its opinion below, t
district court did a thorough job of analyzing each
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plaintiffs' claims, finding that each of them impos
additional requirements and was therefore preempted. As
agree with the district court's analysis and as we see
reason to repeat it here, we adopt those portions of t
district court's opinion. Talbott, 865 F. Supp. at 49- _______
(section II.C); see In re San Juan Dupont Plaza Hotel Fi ___ _____________________________________
Litig., 989 F.2d 36, 38 (1st Cir. 1993) (where district ju ______
produces a well-reasoned opinion that reaches the corre
result, a reviewing court should not write at length mere
to put matters in its own words). We hold that all
plaintiffs' claims are preempted by 360k(a).
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We note, briefly, that the Third Circuit
Michael, 46 F.3d at 1328, 1331, though agreeing in large pa _______
with our analysis, has held that claims for breach of expre
warranty and fraudulent advertising are not preempted by
360k(a). The latter claim is not present in this case,
plaintiffs' fraudulent misrepresentation claim is based
statements made to the FDA, a claim which the Michael cou _______
agreed is preempted. Id. at 1329. The former clai ___
however, is present in this case, and the Third Circuit
position appears to be inconsistent with this circuit
position as set forth in King, 983 F.2d at 1135. We affi ____
the district court's finding that plaintiffs' expre
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warranty claim is preempted, as that result accurate
reflects the law in this circuit. Accord Martello v. CI ______ ________ _
-16- 16
Vision Corp., 42 F.3d at 1167, 1169 (8th Cir. 1994). As____________
noted previously, prior decisions by panels of this court
be overruled only by the full court sitting en banc, abse
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exceptional circumstances not present here. Newman, 49 F. ______
at 11.3
D. Remaining Claims ________________
Plaintiffs advance a number of constitution
arguments challenging Congress' power to enact 360k(a) a
to displace state tort law. We have reviewed these argumen
and find them it be without merit.
III.
Because all of plaintiffs' claims are preempted
360k(a) of the MDA, we affirm the district court
dismissal of this suit. We end with this quotation from t
district court's opinion:
This is a particularly poignant case in
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which the heirs of a woman who died
during angioplasty are being found not to
have the right to seek compensation for
____________________
3. After oral argument, plaintiffs brought to our attenti
Lohr, 56 F.3d at 1335, in which an Eleventh Circuit pan ____
held that a plaintiff's negligent design and neglige
failure to warn claims were not preempted by 360k(a). T
court in Lohr, however, explicitly based its holding on t ____
fact that the device in question had not gone through t
pre-market approval process, but instead was marketed under
510(k) as "substantially equivalent" to an existing devic
Lohr is thus distinguishable from cases, like this one, whe ____
the device was subject to the premarket approval ("PM
process, as the Lohr court itself noted. Id. at 13 ____ ___
("Appellee's heavy reliance on . . . King . . . is misplac ____
because the device at issue in [that case] had undergone t
full PMA process before it entered the market.").
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the damages they have undoubtedly
suffered. The government has vigorously
enforced the applicable criminal and
civil laws. Nevertheless this decision
may cause some, including those who
enacted the law, to question whether
complete preemption of private rights of
action is the most fair and effective
means of balancing the legitimate,
competing interests of promoting
innovation and reasonably assuring the
safety of complex medical devices. It is
axiomatic, however, that the courts must
faithfully give effect to the intentions
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of Congress when they are clearly
expressed by statute, as they have been
in this case. Defendants' motion to
dismiss, therefore, must be granted.
Talbott, 865 F. Supp. at 40. _______
Affirmed. _________
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